The Americans buy the new drug by online 6 month ago
The for many expected little pink pill ( “pink pill”), the first drug to increase sexual desire in women, is now available in pharmacies in the United States. Under the name of Addyi and marketed by Sprout Pharmaceuticals Inc., the release of flibanserin will serve to check the possible side effects were sufficient for rejection of its release promoting part of the medical community and reason The US Federal Drug Agency (FDA), which despite all gave its approval. For $ 400 a month, which are reduced to between 30 and 75 dollars for those with medical coverage through the co – payment system, from October 17 any American citizen can acquire prescription medication.
Some seven million Americans suffer from lack of sexual appetite
The Addyi is made to act on brain chemicals associated with mood and appetite, in a way similar to antidepressants. To such an extent it is related to them that at the origin sought the elaboration of another medicine to combat the depression. However, the research eventually led to the search for a substance for the female libido.
Although commonly has called female Viagra, an identification that has been reflected even in the advertising way to counterpose the pink pill Addyi with blue Pfizer, which is the brand Viagra in the United States , experts insist In that it is not a female version of this medicine. Unlike Viagra, flibanserin does not seek to directly modify sexual behavior as in the case of men, for whom it seeks to alleviate erectile dysfunction, but aims to increase appetite by acting in the brain.
It is this latter objective that makes some experts doubt the true efficacy of Addyi, a stumbling block that adds to the possible side effect that can lead to its intake, especially if mixed with alcohol consumption.
The new drug was approved for those women who have reached menopause and who suffer from a hypoactive sexual desire disorder, which is explained as a lack of sexual appetite that includes an emotional anguish.
It is estimated that about seven million American suffer from a lack of this you po, of which about 12% are between 20 and 49 years, according to the latest surveys published by specialized magazines. In many of these cases, the disorders directly affect the sentimental stability of many couples, who seek a medical solution because of the impossibility of having sex.
But not everything has been a medical debate. The egalitarian requirement that women will also have a drug to increase your libido has led to the most progressive sectors to make political banner of approval, including legislative initiatives in the US Congress through the Democratic Party, pressured by mobilizing more of 60,000 activists of different women’s associations.
But political pressure does not always meet health demands. The pharmaceutical analyst Ira Loss already warns that the claims of a part of the medical and scientific community “had already been taken over by the Federal Agency itself” between 2010 and 2013, in which it was denied its marketing in a systematic way. Among the possible side effects attributed to the intake of flibanserin, there is a drop in blood pressure and loss of consciousness. Consequences are heightened if taking Addyi coincides with alcohol or other drugs specifically harmful when mixed.
Hylton Joffe, a director of division of the Federal Drug Agency, assumes the existence of risks, but argues that “will be reasonably managed by the Sprout (the trading company) Pharmaceutical, which has implemented training courses to doctors who Are going to prescribe and include the signing of forms in which patients will have to take the risks before taking them “.
FDA Approves Libido Pill for Women - With Restrictions
Flibanserin can cause low blood pressure, loss of consciousness; Not recommended for use with alcohol
The US Food and Drug Administration on Tuesday approved the so-called “little pink pill” – a controversial drug intended to boost flagging sex drive in women.
Flibanserin (Addyi) becomes the first FDA-approved drug designed to help women with low libido. But that approval also comes with significant restrictions because the drug can cause severe low blood pressure and loss of consciousness, the FDA warned.
Addyi’s label will include a boxed warning saying the drug should not be taken while drinking alcohol, and should not be used with certain other drugs and with women with liver problems.
And the once-daily pill, to be taken at night, can only be prescribed or dispensed by doctors and pharmacists who have been thoroughly briefed on the drug and its benefits and risks, the FDA added.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”
Woodcock said, “because of a potentially serious interaction with alcohol.”
Addyi will be marketed by Sprout Pharmaceuticals, based in Raleigh, NC Cindy Whitehead, Sprout’s chief executive, said the retail price of Addyi had not been decided. But she added it would probably be That comparable to the monthly cost of erectile dysfunction pills Viagra and Cialis : such as, The New York Times Reported.
Dr. Holly Thacker, a women’s health specialist at the Cleveland Clinic, said the FDA’s approval of Addyi “provides an additional, helpful option for women across the country who experience sexual dysfunction. The medication has been studied in 11,000 women and it does improve sexual function in women who have certain sexual problems.
“It does not treat all sexual dysfunction, it will not help all women with sexual problems, but it will have a role in the therapy,” Thacker added. “Just like with any medication – adult women in conjunction with their physician can make an informed decision about whether this is an appropriate therapy for them.”
Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York City, said: “Although the efficacy [effectiveness] of flibanserin is not clear, it seems to be safe. Couples will have the option of finding out whether or not it enhances their sexual relationship. It is clear that flibanserin will not address interpersonal or emotional problems. Nor will it address issues related to painful intercourse. “
The pursuit of a drug for women with low libido has been like a Holy Grail for the pharmaceutical industry, given the enormous popularity and financial windfall from the erectile dysfunction drugs Viagra and Cialis for men since the late 1990s.
And Addyi’s long road to FDA approval – it had been rejected twice by the agency since 2010 – was a contested affair.
Proponents said the drug would provide an important option for millions of American women who suffer from hypoactive sexual desire disorder, which causes persistent or recurring lack of desire.
“This would bring an option to the table that does not currently exist,” said Fred Wyand, spokesman for the American Sexual Health Association, a group that testified in favor of flibanserin during an FDA hearing in June.
But opponents cited a host of concerns about the drug. Among the concerns: symptoms of extreme fatigue and the potential for accidental injuries, as well as questions about the medication’s effectiveness.
An FDA advisory panel voted 18 to 6 in June to recommend the drug’s approval, but the endorsement was somewhat muted. The committee called the drug benefits “moderate” or “marginal,” and the panel members who voted yes said full FDA approval should come with conditions.
Keesha Ewers, founder and chief medical officer of the Functional Sexology Institute, who contends the drug has not been shown to be very effective.
Women in clinical trials for the drug reported, at best, an increase of one additional satisfying sexual event per month, according to FDA documents. Plus, clinical trials have also shown that the drug does not appear to directly boost a woman’s libido, Ewers said.
“Not one person in the studies That Have Been Reported whos has done an Increase in sexual desire,” She Told HealthDay . “What has been reported is a decrease in the distress that is felt about lack of sexual desire.”
That distress is one of the clinical parameters used to diagnose a person with hypoactive sexual desire disorder. And that is what has allowed the drug’s proponents to state that it is useful in treating some women who have sexual dysfunction.
There are also safety concerns about flibanserin. One in five women in clinical trials reported that the drug reported feelings of extreme fatigue and sedation. Accidental injuries associated with this fatigue occurred twice as often in women taking flibanserin compared with those taking placebo, FDA documents showed.
Flibanserin’s backers mounted a marketing campaign called “Even the Score,” which used a gender-right to advocate for the drug’s approval. The campaign received funding from Sprout Pharmaceuticals, Palatin Technologies and Trimel Pharmaceuticals, all of which are working on drugs to treat female sexual disorders.
A number of high-profile groups such as the National Organization of Women signed onto the campaign, which argued that women deserve a medication that helps sexual function since they already have Viagra and Cialis.
“We live in a culture that has historically discounted the importance of sexual pleasure and sexual desire for women,” NOW President Terry O’Neill said in an NPR interview earlier this year. “And, I fear that it’s that cultural attitude that men’s sexual health is extremely important, but women’s sexual health is not so important. “
Other groups in support of Even the Score include the American Sexual Health Association, the Association of Reproductive Health Professionals, the National Association of Clinical Nurse Specialists, the Society for Women’s Health Research, and the Institute for Sexual Medicine.
“What makes me sad, worried, and to be honest, annoyed, is that there are in medical options available for women for whom biological factors are at play. Not one, “said Lynn Barclay, the American Sexual Health Association’s president and CEO, who testified before the FDA advisory committee in June.
Ewers said it’s a false argument to compare flibanserin for women to Viagra or Cialis for men. Viagra works on a man’s body, stimulating blood flow to create easy erections. “That’s an actual physiological function – erection,” she said. “It’s not affecting their desire. It’s affecting their plumbing. “
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